Publication of National Versions of 60601-1 Standards

IEC 60601 is a widely accepted series of standards for the Basic Safety and Essential Performance of Medical Electrical Equipment.

On March 18, 2022, the Association for the Advancement of Medical Instrumentation (AAMI) published the relevant U.S. amendments of the following IEC 60601-1 Standards:

Amendments to the previously published AAMI standards* have been published as follows:

*Note: All the above amendments are currently only published as an amendment to the IEC standard. Publication of the fully amended standard is forthcoming.  

These recently published standards will be utilized for inclusion into FDA’s recognized standards database as well as OSHA’s documented list of “Appropriate Test Standards.” 

A similar set of national standards updates were issued by the Canadian Standards Association (CSA) under the following Canadian national standards:

*Note: All the above amendments are currently only published as an amendment to the IEC standard. Publication of the fully amended standard is forthcoming.  

Regulation updates

The U.S. FDA has recently updated the web-based directory of recognized consensus standards to include all of the above standards. The supplemental information sheets for all of the above standards indicate a required transition date for new submittals to the FDA of Dec. 17, 2023, after which all of the new standards will be required. Health Canada’s standards updates and transitional periods may be similar to the US FDA requirements.

The OSHA NRTL program currently includes all amendments to the base standard, therefore AAMI ES 60601-1 and its collaterals, including the above amendments are suitable for use for a product to bear an NRTL marking.

For EU market access, the EN versions of the standards have not been updated or published in the Official Journal of the European Union. However, under council directive 2017/745 (Medical Device Regulation), manufacturers must consider state of the art and typically compliance to, or a gap assessment and appropriate risk mitigations will need to be in place for compliance with the EU MDR.

Pathways to Certification and Regulatory Approval

With these standards updates, manufacturers should focus efforts and their engagement with UL Solutions to help confirm compliance with the most recent updates to the standards. The current publications of standards, regulatory requirements and national deviations clearly describe the transition periods for supporting regulatory approvals, NRTL Marking and issuance of CB Scheme reports.

The current CB Scheme for the above standards now includes U.S. National Differences. The previous version of the standard did include country deviations for Canada, U.K., Israel, Japan and Korea. We anticipate that these national differences are forthcoming during the next several months.

Our global network of laboratories have achieved scope expansions to cover the updated CB Scheme standards, and national differences will be applied as soon as they are available and as needed by manufacturers.

Since the publication of the IEC versions of the above standards in late 2020, our main testing laboratories have achieved CBTL status in the following locations:

Dedicated to healthcare industry innovation, we leverage decades of technical, regulatory and clinical expertise to help you manage regulatory challenges and help you bring your products to market faster.

Our testing and compliance engineers work closely with standards committees to stay up to date on all the new amendments and upcoming changes. These committees include the American National Standards Institute (ANSI) and the International Electrotechnical Commission (IEC). UL Solutions has several U.S. FDA ASCA-accredited testing laboratories across the U.S., Europe, and Asia.

To learn more, contact us.